BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 5131451 · Received October 7, 2015

    Report

    Report Number
    1416980-2015-38210
    Event Type
    Malfunction
    Date Received
    October 7, 2015
    Date of Event
    August 19, 2015
    Report Date
    October 6, 2015
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND THE EVALUATION IS COMPLETE. THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED THROUGH AN EVENT HISTORY LOG REVIEW. THE HOMECHOICE DEVICE RECEIVED A RETURNED INSTRUMENT TESTING EVALUATION (RITE), INCLUDING FUNCTIONAL AND ELECTRICAL TESTING OF THE DEVICE AND SIMULATED USE TESTING. INTERNAL AND EXTERNAL VISUAL INSPECTION WAS PERFORMED AND NO ISSUES WERE NOTED. A SERVICE HISTORY REVIEW SHOWED NO FAILURES/PROBLEMS THAT WERE THE SAME AS, OR SIMILAR TO, THE REPORTED ISSUE. IN ADDITION, THERE WAS NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. UPON CONCLUSION OF THE INVESTIGATION, THE CAUSE WAS DETERMINED TO BE USE ERROR, TIDAL TOTAL ULTRAFILTRATION REMOVAL SET TOO LOW. THE HOMECHOICE APD SYSTEMS TRAINER¿S GUIDE GIVES INSTRUCTIONS ON HOW TO SET THE TIDAL THERAPY SETTINGS. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING EVALUATION OF A RETURNED HOMECHOICE DEVICE, ONE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT WAS IDENTIFIED. THIS EVENT OCCURRED IN THE THERAPY INITIATED ON (B)(6) 2015 AT 23:41:47. DURING NIGHT DRAIN CYCLE SIX, THE PATIENT'S ULTRAFILTRATION READING WAS 1995ML, INDICATING THE HOME PATIENT DRAINED 1335ML MORE THAN THEIR MAXIMUM PROGRAMMED FILL VOLUME OF 2200ML. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662915 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1